Spinal DeformityPAMNCT02950532
Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures
An observational study of Spinal Deformity and Spinal Fractures, run by AO Clinical Investigation and Publishing Documentation at 5 sites in 5 countries.
Trial summary
The objective of this investigation is to confirm the results obtained in a pilot study showing that certain radiological parameters based on computed tomography (CT) scans seem to reliably detect posterior ligament complex (PLC) injury without the need for Magnetic Resonance Imaging (MRI) Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Deformity, Spinal Fractures, Spinal Injuries
- What is being tested?
- Retrospective radiological evaluation
- How many people
- 60 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Oct 2016to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The participating study sites will retrospectively identify all eligible patients in the medical charts (i.e. who meet all of the inclusion and none of the exclusion criteria). If required by local regulations, patients choosing to participate will sign and date an informed consent form (ICF).
Who may be able to join
- Age 18 to 60 years
- A3/A4 TL fracture between T11-L2 with or without PLC injury
- Pre-treatment CT scan and MRI. Radiographs (if available)
- Signed Informed consent, if required by EC/IRB
Who cannot join
- Pathological fractures
- Multilevel contiguous and non-contiguous injuries
- Fractures with obvious spinous process split indicating tension band failure such as AO type B1 injuries
- Fractures with translation injuries or dislocations such as AO type C injuries
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures (T11-L2): A Diagnostic Test Study to Analyze Sensitivity and Specificity
The objective of this investigation is to confirm the results obtained in a pilot study showing that certain radiological parameters based on computed tomography (CT) scans seem to reliably detect posterior ligament complex (PLC) injury without the need for Magnetic Resonance Imaging (MRI)
Read the detailed description
Integrity of posterior ligament complex (PLC) has an important bearing on the treatment strategies for thoracolumbar (TL) fractures. Magnetic Resonance Imaging (MRI) is the gold standard to confirm PLC injury. The routine use of MRI has its limitations especially since in most trauma centers MRI is not the primary assessment for TL fractures due to reduced availability, increased cost and its adverse applicability in trauma setting and in case of a polytrauma. In contrast computed tomography (CT) scans are an integral part of trauma evaluation protocols, are accurate in spine fracture diagnosis and are performed in less time, making them suitable to assess polytrauma scenarios. In a recent pilot study, a number of radiological parameters based on CT scans have shown to reliably detect PLC injury when compared to MRI. The aim of the study is to reconfirm and validate these CT based parameters to assess PLC injury compared to MRI.
- Conditions
- Spinal Deformity, Spinal Fractures, Spinal Injuries, Kyphosis
- Being tested
- Retrospective radiological evaluation
- Keywords
- Posterior ligamentous complex, Thoracolumbar fractures, Interspinous distance, Local kyphosis
- Medical subject headings
- Spinal Fractures, Spinal Injuries, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective radiological evaluationOther
Radiological evaluation will be performed in already existing imaging exams. Superior-inferior end plate angle (SIEA), vertebral body height (BH), local kyphosis (LK), inter-spinous distance (ISD) and inter-pedicular distance (IPD) will be measured in CT scans and radiographs (if available). PLC injury will be determinated with the gold standard method (MRI).
| Study group | Role | What they receive |
|---|---|---|
| Cases | Retrospective radiological evaluation in cases presenting A3 or A4 TL burst fractures (AOSpine classification) between T11 to L2 with or without suspected PLC injury Receives: Other: Retrospective radiological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Local kyphosis (LK) and/or Inter-spinous distanceI (SD)
Sensitivity of LK and/or ISD Is defined as the proportion of patients with PLC injury correctly diagnosed by an increase in LK and/or ISD difference compared to MRI. The Specificity si defined as the proportion of patients with PLC injury correctly diagnosed by an increase in LK and/or ISD difference compared to MRI. The gold standard is a diagnostic test and it is the best accepted test that is assumed to be able to determine the true disease state. It is considered as the reference method or the best test available.
Measured: CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).
Secondary outcomes (3)
Sensitivity and specificity of superior-inferior end plate angle (SIEA)
Is defined as the proportion of patients with PLC injury correctly diagnosed by a increase in SIEA compared to MRI.
Measured: CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).
Sensitivity and specificity of vertebral body height (BH)
Is defined as the proportion of patients with PLC injury correctly diagnosed by an decrease in BH compared to MRI.
Measured: CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).
Sensitivity and specificity of inter-pedicular distance (IPD)
Is defined as the proportion of patients with PLC injury correctly diagnosed by a increase in IPD compared to MRI.
Measured: CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shanmuganathan Rajasekaran, Prof. MD, Principal investigator, Ganga HospitalTest Testing, MD, Study chair, TESTING
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950532
- Sponsor's protocol ID
- AOCID_PAM
- Acronym
- PAM
- Status last verified
- Aug 2020
- First submitted
- 18 Oct 2016
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures (T11-L2): A Diagnostic Test Study to Analyze Sensitivity and Specificity
- ClinicalTrials.gov ID
- NCT02950532
- Acronym / sponsor ID
- PAM / AOCID_PAM
- Conditions
- Spinal Deformity, Spinal Fractures, Spinal Injuries, Kyphosis
- Keywords
- Posterior ligamentous complex, Thoracolumbar fractures, Interspinous distance, Local kyphosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this investigation is to confirm the results obtained in a pilot study showing that certain radiological parameters based on computed tomography (CT) scans seem to reliably detect posterior ligament complex (PLC) injury without the need for Magnetic Resonance Imaging (MRI)
Detailed description
Integrity of posterior ligament complex (PLC) has an important bearing on the treatment strategies for thoracolumbar (TL) fractures. Magnetic Resonance Imaging (MRI) is the gold standard to confirm PLC injury. The routine use of MRI has its limitations especially since in most trauma centers MRI is not the primary assessment for TL fractures due to reduced availability, increased cost and its adverse applicability in trauma setting and in case of a polytrauma. In contrast computed tomography (CT) scans are an integral part of trauma evaluation protocols, are accurate in spine fracture diagnosis and are performed in less time, making them suitable to assess polytrauma scenarios. In a recent pilot study, a number of radiological parameters based on CT scans have shown to reliably detect PLC injury when compared to MRI. The aim of the study is to reconfirm and validate these CT based parameters to assess PLC injury compared to MRI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Retrospective radiological evaluationRetrospective radiological evaluation in cases presenting A3 or A4 TL burst fractures (AOSpine classification) between T11 to L2 with or without suspected PLC injury |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The participating study sites will retrospectively identify all eligible patients in the medical charts (i.e. who meet all of the inclusion and none of the exclusion criteria). If required by local regulations, patients choosing to participate will sign and date an informed consent form (ICF).
Key inclusion criteria (4 listed)
- Age 18 to 60 years
- A3/A4 TL fracture between T11-L2 with or without PLC injury
- Pre-treatment CT scan and MRI. Radiographs (if available)
- Signed Informed consent, if required by EC/IRB
Key exclusion criteria (4 listed)
- Pathological fractures
- Multilevel contiguous and non-contiguous injuries
- Fractures with obvious spinous process split indicating tension band failure such as AO type B1 injuries
- Fractures with translation injuries or dislocations such as AO type C injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective radiological evaluationRadiological evaluation will be performed in already existing imaging exams. Superior-inferior end plate angle (SIEA), vertebral body height (BH), local kyphosis (LK), inter-spinous distance (ISD) and inter-pedicular distance (IPD) will be measured in CT scans and radiographs (if available). PLC injury will be determinated with the gold standard method (MRI). | Other | Cases |
Primary outcome
Sensitivity of Local kyphosis (LK) and/or Inter-spinous distanceI (SD)
Time frame: CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).
Sensitivity of LK and/or ISD Is defined as the proportion of patients with PLC injury correctly diagnosed by an increase in LK and/or ISD difference compared to MRI. The Specificity si defined as the proportion of patients with PLC injury correctly diagnosed by an increase in LK and/or ISD difference compared to MRI. The gold standard is a diagnostic test and it is the best accepted test that is assumed to be able to determine the true disease state. It is considered as the reference method or the best test available.
3 secondary outcomes
Sensitivity and specificity of superior-inferior end plate angle (SIEA)
Time frame: CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).
Sensitivity and specificity of vertebral body height (BH)
Time frame: CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).
Sensitivity and specificity of inter-pedicular distance (IPD)
Time frame: CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Individual participant dataSharing planned: Undecided. Publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanmuganathan Rajasekaran, Prof. MD principal investigator
Ganga Hospital
Test Testing, MD study chair
TESTING
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Deformity and Spinal Fractures, run by AO Clinical Investigation and Publishing Documentation at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China, Egypt, India, South Korea, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Local kyphosis (LK) and/or Inter-spinous distanceI (SD) (time frame: CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.